Lacrimal Passage ObstructionNCT04240938
Adult Dacryocystocele Among Patients With Epiphora
A study testing Dacryocystorhinostomy in people with Lacrimal Passage Obstruction, run by Minia University at 1 site in Egypt.
Trial summary
Patients with lacrimal dacryocystocele were chosen for the study. Dacryocystorhinostomy were done for them after their evaluation. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Lacrimal Passage Obstruction
- What is being tested?
- Dacryocystorhinostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2017to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lacrimal sac mucocele
- Acquired type
Who cannot join
- No previous lacrimal sac surgery
- Suspected lacrimal sac malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adult Encysted Dacryocystocele: Prevalence Among Patients With Epiphora and Its Management
Patients with lacrimal dacryocystocele were chosen for the study. Dacryocystorhinostomy were done for them after their evaluation.
Read the detailed description
Evaluation for lacrimal passage in the included patients using syringing, probing and dye disappearance test. Dacryocystorhinostomy were done for all patients and followed up for at least 6 months.
- Conditions
- Lacrimal Passage Obstruction
- Being tested
- Dacryocystorhinostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DacryocystorhinostomyProcedure or surgery
Anastomosis between lacrimal sac and nasal cavity
| Study group | Role | What they receive |
|---|---|---|
| Lacrimal sac mucocele | Other | Adult patients with lacrimal sac mucocele Receives: Procedure: Dacryocystorhinostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patency of the lacrimal passage
Disappearance of the watering of the eye reported by the patients and by fluorescein disappearance test
Measured: 2 weeks
Disappearance of lacrimal sac swelling
No evident swelling in the medial side of the eye
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Mar 2017
- Primary completion21 Nov 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lacrimal Passage ObstructionStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Adult Dacryocystocele
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Farag Khalil Ibrahiem, Minia University
- Investigators
- Mohamed F Ibrahiem, MD, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240938
- Sponsor's protocol ID
- Minia2020
- Status last verified
- Jan 2020
- First submitted
- 21 Jan 2020
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adult Encysted Dacryocystocele: Prevalence Among Patients With Epiphora and Its Management
- ClinicalTrials.gov ID
- NCT04240938
- Acronym / sponsor ID
- Minia2020
- Conditions
- Lacrimal Passage Obstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 21 Nov 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with lacrimal dacryocystocele were chosen for the study. Dacryocystorhinostomy were done for them after their evaluation.
Detailed description
Evaluation for lacrimal passage in the included patients using syringing, probing and dye disappearance test. Dacryocystorhinostomy were done for all patients and followed up for at least 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Adult Dacryocystocele
| Arm | Type | Receives |
|---|---|---|
| Lacrimal sac mucocele | Other | Procedure: DacryocystorhinostomyAdult patients with lacrimal sac mucocele |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Lacrimal sac mucocele
- Acquired type
Key exclusion criteria (2 listed)
- No previous lacrimal sac surgery
- Suspected lacrimal sac malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DacryocystorhinostomyAnastomosis between lacrimal sac and nasal cavity | Procedure or surgery | Lacrimal sac mucocele |
Primary outcome
Patency of the lacrimal passage
Time frame: 2 weeks
Disappearance of the watering of the eye reported by the patients and by fluorescein disappearance test
Disappearance of lacrimal sac swelling
Time frame: 1 month
No evident swelling in the medial side of the eye
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed F Ibrahiem, MD principal investigator
Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dacryocystorhinostomy in people with Lacrimal Passage Obstruction, run by Minia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patency of the lacrimal passage (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.